ReDe Mask— 510(k) K161953
Substantially EquivalentTereopneuma
FDA 510(k) clearance K161953 for ReDe Mask, Substantially Equivalent on 2017-02-17. Applicant: Tereopneuma. Device class: 2.
Clearance details
- Applicant
- Tereopneuma
- Product code
- Code PRK
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.